Flexible support for gel wraps

ABSTRACT

A two-ply bandage for treatment of skin while providing orthopedic support having a first layer of gel for contacting the skin and a second layer of an elastic and supportive loop portion of a hook and loop fastener. The product is economically manufactured in the form of long rolls or as a sheet and is easily cut to any desired shape.

This application claims the benefit of U.S. Provisional Application60/226,602, filed Aug. 21, 2000.

BACKGROUND OF THE INVENTION

The present invention relates to a medical or surgical bandage suitablefor use in providing musculo-skeletal support and treatment of skinconditions. In particular, the invention relates to positioning a gelagainst the skin utilizing a stretchable bandage that also provides theadded benefit of orthopedic, or musculo-skeletal, support for the jointor portion of the body on which the bandage is wrapped.

More specifically, this invention relates to a composite materialconsisting of two layers; a layer of gel bonded to a stretchable carrierlayer of a rigid and elastic loop portion of a hook and loop fastener.The stretch carrier layer is useful for positioning the gel layer inplace on the body while at the same time providing substantialmusculo-skeletal support to the portion of the body around which thebandage is wrapped.

SUMMARY OF THE INVENTION

This invention relates to a composite structure which incorporates thepressure therapy features of a rigid yet stretchable carrier materialwith a silicone gel for treatment of skin conditions. Silicone gelmaterials are used in the medical field for the management of suchconditions, for example, as dermal scarring, varicose veins and stasisulcers. These silicone materials soften scar tissue and improve thecosmetic as well as functional aspects of scars for instance.

There is a need in the medical and veterinary fields to combinesupportive (pressure) therapy with a gel treatment, particularly on theextremities of the body. In the case of veterinary applications, fur isused herein interchangeably with skin. Supportive pressure therapy isuseful, for example, to provide musculo-skeletal support for joints andmuscles, and in the treatment of carpal tunnel syndrome, arthritis andtennis elbow. This is not easy or convenient under present methods.Typically in the medical and veterinary fields supportive pressuretherapy is provided using compression garments or wraps. When used witha gel, a person must typically apply a layer of gel to the area of thebody to be treated followed by wrapping another material such as acompression garment or wrap to keep the gel in position. The materialstypically used don't provide the elastic support usually desired andtherefore require many wraps of the material. Furthermore, typicalmaterials lose much of their elasticity after only a couple of uses.

Hook and loop fasteners are now available with rigid yet stretchableloop portions that have a modulus of elasticity of about 50%, with nostretch memory. The strong elastic property provided by the stretchableloop portion makes it possible for a bandage using this material to bewrapped only once around a part of the body while maintaining contactwith the skin to be treated. By applying a surface layer of silicone gelto the flat side (non-loop surface) of a stretchable loop portion of ahook and loop fastener, it was discovered that bandages can be producedwhich provide a surface layer of silicone for uniform skin contact withthe added benefit of musculo-skeletal support. The bandage of thisinvention having a stretchable loop portion as the carrier layer for thegel can therefore follow the many shapes and anatomical contours of thebody while at the same time providing secure positioning of the gel onthe skin of the user. The combination of stretch carrier and gel layerprovides greater comfort to the user because the bandage allows formovement and flexing of the body without reduction in the bandageseffectiveness, i.e. support and resistance to slipping. Thus, thesupport provided by this invention offers the wearer of the bandagegreater comfort and durability and makes for the ideal bandage forrepeated usage and/or usage over long periods of time.

This invention is an improvement over the prior art in that (a) thecarrier material is rigid and elastic so that substantial orthopedicsupport (i.e., musculo-skeletal support) is provided by just a one layerwrapping, (b) the product is far more durable than Lycra® and otherknown, thin elastic based products commonly available, (c) both pressureand silicone therapies may be applied concomitantly by this inventionand therefore eliminating a separate and/or repeated process of fittingmore than one material individually, and (d) patient compliance may beimproved because continued, even long term, comfortable use of theproduct is possible without loss of support from the carrier material.Furthermore, the carrier of the present invention provides the addedbenefit of a bandage that supplies even pressure to the body across thearea of the bandage being treated.

The manufacturing process of this invention lends itself to large-scaleproduction in either flat sheets or long rolls. Final shapes oflimitless configurations can then easily be cut from the sheets orrolls. This provides for rapid and cost effective production ofcustom-made shapes for any given application or patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view illustrating the use of one embodiment ofthis invention on the knee of a user.

FIG. 2 is an embodiment illustrating gel layer 5 bonded to carrier 10having loop surface 15.

FIG. 3 illustrates carrier 10, having a loop surface 15, bonded to gellayer 5.

FIG. 4 illustrates closure strip 20

FIG. 5 illustrates a method of manufacture using gel bath 30 and carrier10

FIG. 6 illustrates river of carrier 10 and uncured gel compound 40.

FIG. 7 is a perspective view illustrating the use of particularembodiments of this invention adjacent to the knee joint of a user.

FIG. 8 is a perspective view illustrating the use of an embodiment ofthe, present invention about the thigh of a user, and showing loopsurface 15 of the bandage and closure strips 20.

DETAILED DESCRIPTION OF THE INVENTION

The description provided below references FIGS. 1 through 8 as part ofthe disclosure and the associated reference numerals.

The device of the present invention, shown in FIGS. 1 through 3, 7 and8, is generally described as a rigid yet stretchable bandage with asilicone gel coating 5 on one side. The carrier 10 is a thick,stretchable loop portion of a hook-and-loop fastener such as Velcro®. Ina particular embodiment, carrier 10 is about {fraction (1/8)} inchthick. The silicone gel used in gel 5 is commercially available aseither a 1:1, 3:1, or 10:1 mixture of a polydiorganosiloxane resin and acatalyst. Generally speaking, the silicone gel is an addition curedpolydimethyl-siloxane gel. This type of gel is well described in theliterature, including some of the existing patent literature (e.g. U.S.Pat. No. 4,991,574 (“Pocknell”) which is incorporated herein byreference). There is no particular reason to limit our device tosilicone gel, if there are other gels that provide clinical benefit.Further, additives may be introduced into the gel, including, forexample, oils, Ben-Gay™, and other topical medications and emolumentsthat seep into the skin area on which the gel is applied. Although othergels may be used, silicone gel has the special benefit of reducing theappearance of hypertrophic and keloid scarring. The advantages ofsilicone gel are widely known and are also well described in theexisting patent literature (e.g. U.S. Pat. No. 5,759,560 (“Dilon”), U.S.Pat. No. 5,656,279 (“Dillon”), and U.S. Pat. No. 5,895,656 (“Hirschowitzet al.”) all the contents of which are herein incorporated by reference.Silicone gel is also known to be hydrophobic, so it won't break down orchange characteristics in the presence of water or sweat. Cured siliconegel is cohesive (retains its shape) but is not very strong. It can beeasily torn, and to be handled by the average person, it must bereinforced with some alternate carrier material.

In the present invention, carrier 10 is preferably a commerciallyavailable loop portion of a stretchable hook-and-loop fastener such as,for example Velstretch®. This “stretch” carrier is essentially thetraditional loop portion of a hook-and-loop fastener woven with anelastic material. Depending on the degree of “stretch” needed, differentelastic interweaves may be used, and from which a stretch ofapproximately 50% in one direction may be obtained. This carrier, orsubstrate, provides the backbone, or compressive force, necessary toapply the silicone gel to any contour on the body, especially joints,both large and small, while also providing the benefit of support to theunderlying tissue. The thickness of the carrier also provides support tothe joint, so that the pain and discomfort of joint inflammation due toa variety of medical conditions is minimized. An added benefit of thecarrier is to provide protection, for example, from abrasion, to thesurface of the skin upon which the invention is applied. The support andprotective aspects of the present invention, as described above, easilylend themselves to uses on animals as well.

In a particularly preferred embodiment, the “fuzzy” side or “loop” side15 of the carrier 10 is used as the carrier for the gel. The bandage maybe secured about the afflicted joint or area of the body with acomplimentary strip of the hook portion 20 (FIG. 4) of a hook and loopfastener material which may be used to keep the bandage closed aroundthe joint or area of the body. Multiple strips or one large strip ofwidth equal to approximately the width of the bandage may also be usedto provide proper securing of the bandage as shown in FIG. 7.

In one particularly preferred embodiment, the combined product of thisinvention has the “loop” side, or loop portion 15 (the soft side), ofthe stretch carrier 10 on one side and a layer of silicone gel on theother. The gel goes against the skin, and the product is fixed in placeby wrapping the body portion with the bandage and applying acomplimentary “hook” or closure strip 20 of fastener material at anypoint along the bandage seam.

An embodiment of this invention could be provided in a roll form, about3″ wide by about 1 foot long for applications such as those currentlyemploying use of an Ace® type bandage. In this configuration, thepresent invention can replace the application of Ace-type bandages formusculo-skeletal support and other orthopedic bandages which arespecially configured to fit knees, ankles, wrists, elbows, and otherproblematic joints. Other dimensions applicable to specific applicationsare also contemplated, such as for use around a thigh or forearm.

It is an embodiment of the present invention for the stretchable carrier10 to provide a platform for the gel to be continuously applied againstany existing scar, which will in turn provide the widely understoodbenefit of reduced scar appearance. Because the gel is deposited on thecarrier 10 while the carrier 10 is in the un-stretched position, itshould be understood that, as the carrier 10 is expanded, the gel alsoexpands in the same direction. This will allow air to circulate into thetreated area, reducing discomfort due to sweating, yet still provide thebenefit of the gel applied against the scar. Further, as the carrier 10is expanded and then closed using the hook section, the carrier 10provides compression and support to the affected area.

The silicone gel provides an additional comfort factor of “coolness”against the skin, which is not diminished to any large degree by keepingthe present invention in place for the required period. Because thepresent invention is comfortable, supportive, adaptable, stretchable,trimmable, usable on any joint or area of the body around which it canbe wrapped, it is expected to result in higher patient compliance withthe treatment.

A method of manufacturing the present invention is shown in FIG. 5, anddescribed as follows.

The desired gel is mixed as designated by the material manufacturer,i.e. 1:1, 3:1, or 10:1 parts resin and catalyst, although the mixturecan be varied to obtain different degrees of tack from the final curedgel. The mixture is poured onto a flat surface, such as large sheet ofpolycarbonate, and allowed to settle until it is a consistent thickness.The gel, after having been allowed to settle, has a consistent thicknessand is surrounded by an appropriate sized wall to contain the gel on thepolycarbonate surface. In one embodiment, the gel thickness isapproximately 2 mm, although the thickness may vary from as little as0.5 mm up to 4 mm. Meanwhile, the carrier 10 may be washed in a mildsoapy solution such as Ivory® soap to remove the oils and agents used inprocessing the fabric, and allowed to air dry. After the gel is settledto a consistent thickness (about 20-60 minutes) the dry carrier 10 isplaced on top with the loop surface of the carrier 10 away from the gel.The assembled materials are then allowed to cure. In a preferredembodiment, the combined gel and carrier 10 are placed in an oven for1-3 hours and at a temperature of about 100 to 180 degrees centigradeuntil the gel is cured. The cured, assembled materials are then removedfrom the oven and can then be cut into any shape desired.

The present invention also lends itself well to mass production bycoextrusion as shown in FIG. 5. In this embodiment, stretchable carrier10 is continuously unrolled from a large roll of material onto a bath 30of gel. As the carrier 10 is removed from the bath 30 a layer of gel 40adheres to the carrier 10 and settles to a uniform thickness. The streamof combined carrier/gel is then passed through a heating oven and cured.At the other end of the oven are take-up rolls and/or cutting fixturesto facilitate rolling or cutting the cured product into any desiredconfiguration.

In another embodiment shown in FIG. 6, an amount of gel 40 is depositedonto a river of carrier 10 as the carrier 10 passes beneath the gel. Alayer of gel is formed on the side of the carrier 10 opposite the loopsand the gel is allowed to settle to a uniform thickness. The river ofcombined carrier/gel material is then passed through a heating oven andcured. At the other end of the oven are take-up rolls and/or cuttingfixtures to facilitate rolling or cutting the cured product into anydesired configuration.

Using either of the previous embodiments, there are specific productiontechniques which will result in a consistent layer of gel being appliedto the flat side of the stretch carrier 10, opposite the loop side.

1-5. (canceled)
 6. A method for providing musculo-skeletal support whichcomprises the steps of: (a) wrapping a stretchable, supportive wraparound a portion of a body in need of musculo-skeletal support, whereinthe wrap comprises a gel layer having a skin contacting surface and anopposite adhesion surface and a stretchable carrier layer having a loopsurface and an opposite adhesion surface, with the adhesion surfacesbeing bonded together to form the wrap; (b) stretching the wrap aroundthe portion to be supported; and (c) securing the wrap in a closedposition with a one or more closure strips.
 7. The method of claim 6,wherein the gel layer is a silicone gel.
 8. The method of claim 6,wherein the stretchable carrier is a stretchable loop portion of a hookand loop fastener.
 9. The method of claim 6, wherein the stretchablecarrier has a modulus of elasticity of about 50%.
 10. The method ofclaim 6, wherein the closure strip is the hook portion of a hook andloop fastener.
 11. A method for providing a skin treatment whichcomprises the steps of: (a) wrapping a stretchable, supportive wraparound a portion of a body having skin in need of treatment, wherein thewrap comprises a gel layer having a skin contacting surface and anopposite adhesion surface and stretchable carrier layer having a loopsurface and an opposite adhesion surface, with the adhesion surfacesbonded together to form the wrap; (b) stretching the wrap around theportion of the body to be treated, and (c) securing the wrap in a closedposition with one or more closure strips.
 12. The method of claim 11,wherein the gel layer is a silicone gel.
 13. (canceled)
 14. The methodof claim 11, wherein the carrier has a modulus of elasticity of about50%.
 15. The method of claim 11, wherein the closure strip is the hookportion of a hook and loop fastener. 16-27. (canceled)
 28. The method ofclaim 6, wherein the wrap is a bandage for a joint or a muscle.
 29. Themethod of claim 28, wherein the joint is a knee, an ankle, a wrist, oran elbow.
 30. The method of claim 29, for use in the treatment of carpaltunnel syndrome.
 31. The method of claim 29, for use in the treatment ofarthritis.
 32. The method of claim 29, for use in the treatment oftennis elbow.
 33. The method of claim 28, for use in a veterinaryapplication.
 34. The method of claim 6, wherein the silicone gel is acured polydiorganosiloxane resin.
 35. The method of claim 34, whereinthe gel layer contains an additive.
 36. The method of claim 35, whereinthe additive is a topical medication or an emolient.
 37. The method ofclaim 28, wherein the closure strip is approximately the width of thebandage.
 38. The method of claim 11, wherein the wrap is a bandage andwherein the skin treatment reduces the appearance of scarring.
 39. Themethod of claim 11, wherein the silicone gel is a curedpolydiorganosiloxane resin.
 40. The method of claim 39, wherein the gelcontains an additive.
 41. The method of claim 40, wherein the additiveis a topical medication or an emolient.
 42. The method of claim 38,wherein the closure strip is approximately the width of the bandage.